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Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

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ClinicalTrials.gov Identifier: NCT00667563
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : April 11, 2014
Last Update Posted : February 29, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cervical Cancer
Nonneoplastic Condition
Precancerous Condition
Interventions Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Genetic: DNA analysis
Genetic: polymerase chain reaction
Other: cytology specimen collection procedure
Procedure: colposcopic biopsy
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Period Title: Overall Study
Started 150
Completed 126
Not Completed 24
Reason Not Completed
Protocol Violation             24
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
Enrolled in study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
30.8  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
150
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
Hide Description Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Time Frame 52 weeks from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Grade 3/4 adverse events per 100 patient
6.0
(3.12 to 11.58)
2.Primary Outcome
Title Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
Hide Description Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Time Frame Screening/Week 0, Weeks 2, 10, 26, and 52.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
11
3.Primary Outcome
Title Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
Hide Description Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population with undetectable HPV-16 levels at baseline
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: participants
95
4.Primary Outcome
Title Number of Patients With a Significant Increase in HIV Viral Load
Hide Description Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions
Time Frame Screening/week 0, weeks, 2, 10, 26 and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
7
5.Primary Outcome
Title Number of Patients With Detectable Antibodies to HPV-6
Hide Description Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Time Frame 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol participants with undetectable antibodies to HPV-6 at baseline
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: participants
88
6.Primary Outcome
Title Number of Patients With Detectable Antibodies to HPV-11
Hide Description Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Time Frame 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: participants
110
7.Primary Outcome
Title Number of Patients With Detectable Antibodies to HPV-18
Hide Description Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
Time Frame 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population of participants with undetectable HPV-18 antibodies at baseline
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description:

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

Overall Number of Participants Analyzed 104
Measure Type: Number
Unit of Measure: participants
94
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gardasil Vaccination
Hide Arm/Group Description

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

DNA analysis: Weeks 0, 2, 10, 26, and 52.

polymerase chain reaction: Screening, week 36, and week 52.

cytology specimen collection procedure: Screening, week 36, and week 52.

colposcopic biopsy: Screening, week 36, and week 52.

All-Cause Mortality
Gardasil Vaccination
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gardasil Vaccination
Affected / at Risk (%) # Events
Total   4/150 (2.67%)    
Blood and lymphatic system disorders   
Anemia *  1/150 (0.67%)  1
General disorders   
Fever *  1/150 (0.67%)  1
Infections and infestations   
Meningitis *  1/150 (0.67%)  1
Lung Infection *  1/150 (0.67%)  1
Leptospirosis *  1/150 (0.67%)  1
Nervous system disorders   
Seizure *  1/150 (0.67%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gardasil Vaccination
Affected / at Risk (%) # Events
Total   145/150 (96.67%)    
Gastrointestinal disorders   
Abdominal pain *  35/150 (23.33%)  41
Dyspepsia *  19/150 (12.67%)  22
Vomiting *  10/150 (6.67%)  11
General disorders   
Fatigue *  27/150 (18.00%)  32
Infections and infestations   
Lung Infection *  8/150 (5.33%)  8
Skin Infection *  26/150 (17.33%)  29
Upper Respiratory Infection *  44/150 (29.33%)  60
Vaginal Infection *  21/150 (14.00%)  22
Vulval Infection *  10/150 (6.67%)  10
Metabolism and nutrition disorders   
Anorexia *  21/150 (14.00%)  24
Musculoskeletal and connective tissue disorders   
Arthralgia *  9/150 (6.00%)  11
Back pain *  27/150 (18.00%)  40
Myalgia *  25/150 (16.67%)  34
Pain in extremity *  45/150 (30.00%)  61
Nervous system disorders   
Headache *  34/150 (22.67%)  47
Reproductive system and breast disorders   
Vaginal Discharge *  21/150 (14.00%)  27
Cough *  59/150 (39.33%)  87
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain *  18/150 (12.00%)  22
Skin and subcutaneous tissue disorders   
Pruritus *  41/150 (27.33%)  64
Rash, maculo-papular *  14/150 (9.33%)  16
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jeannette Y. Lee
Organization: AMC
Phone: 5015266712
Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00667563     History of Changes
Other Study ID Numbers: AMC-054
U01CA121947 ( U.S. NIH Grant/Contract )
CDR0000593634 ( Other Identifier: NCI )
First Submitted: April 25, 2008
First Posted: April 28, 2008
Results First Submitted: January 23, 2014
Results First Posted: April 11, 2014
Last Update Posted: February 29, 2016